MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA THREADED FLEX 8.0 X 72MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72200425
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an acl procedure, when inserting a cannula to the patient, a foreign material was found inside the patient.All debris were removed from the patient by using a grasper.Procedure was successfully completed with the same device.No delay and no patient complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images found that there was a detached white piece of plastic or silicone.It appeared to have come from the inner seal of the cannula.A visual inspection revealed that the piece retrieved in surgery was a part of the proximal y-slit seal.It likely broke off when the obturator was inserted.The remainder of the seals did not appear to have any problems.There was also some plastic deformation at the distal end from use.There was not significant debris.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the following warnings and precautions related to the reported failure: read these instructions completely prior to use.If necessary a wetted obturator may ease insertion.A clinical evaluation concluded that the foreign material came from inside the cannula and was successfully retrieved from the patient.The procedure was completed using the same device.No patient injuries or adverse consequences were reported.Since no patient injuries were reported no further clinical/medical assessment is warranted at this time.The complaint was confirmed and the root cause was associated with component failure.Factors that could have contributed to the reported event include a greater number of insertions than anticipated for a single use device or off-axis insertion.No containment or corrective actions are recommended at this time.

• Brand Name: CANNULA THREADED FLEX 8.0 X 72MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11319367
• Report Number: 1219602-2021-00306
• Device Sequence Number: 3283401
• Product Code: NBH
• UDI-Device Identifier: 03596010597021
• UDI-Public: 03596010597021
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2022
• Device Model Number: 72200425
• Device Catalogue Number: 72200425
• Device Lot Number: 425191017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention